Description

This 2-hr session will provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

Areas Covered in the Seminar:

- What Constitutes An Atypical or Out of Specification Result?
- The Barr Decision of 1993 and Its Impact on OOS Investigations.
- The FDA Guidance for Industry on Investigating OOS Test Results.
- Reporting Data.
- Conducting the Investigation.
- Creating an Investigation Checklist
- Considering Other Batches
- Retesting
- Evaluating the Outcomes: Is there an assignable cause?
- Documenting the Investigation.
- Utilizing Outcomes for Continuous Improvement.
- Questions and Discussions.